BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPOC BGEM TEST CARD

    MDR report key: 2601891 · Received March 26, 2010

    Report

    Report Number
    3004959793-2010-00001
    Event Type
    Other
    Date Received
    March 26, 2010
    Date of Event
    March 16, 2010
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TEST RESULT WAS LABELED AS CA++. ALL LABELING FOR SYSTEM STATES IONIZED CALCIUM. DEVICE IS PERFORMING AS PER SPECIFICATION AND DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2010 AT 21:00, A CALCIUM RESULT OF 5.6 MG/DL WAS REPORTED FROM THE EPOC BLOOD ANALYSIS SYSTEM. THE TREATING PHYSICIAN INTERPRETED THE RESULT AS A LOW (BELOW NORMAL RANGE) TOTAL CALCIUM MEASUREMENT. THE 100 MG OF CALCIUM GLUCONATE WAS ADMINISTERED TO THE PT VIA IV OVER 30 MINS. THE CALCIUM RESULT FROM THE EPOC BLOOD ANALYSIS SYSTEM IS AN IONIZED CALCIUM MEASUREMENT WITH A REFERENCE RANGE OF 4.1 TO 5.2 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOC BGEM TEST CARD CHL, CEM, JFP, JPI, JGS, CGA CHL EPOCAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DA Other